K102965 is an FDA 510(k) clearance for the CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Medtrade Products , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on December 8, 2010, 64 days after receiving the submission on October 5, 2010.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K102965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2010 |
| Decision Date | December 08, 2010 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | — |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |